QUILT-3.032: A Multicenter Clinical Trial of Intravesical Bacillus Calmette-Guerin (BCG) in Combination With ALT-803 (N-803) in Patients With BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer
This is a Phase II/III, open-label, single-arm, multicenter study of intravesical BCG plus
N-803 or N-803 only in patients with BCG unresponsive high grade non-muscle invasive bladder
cancer (NMIBC). All patients treated in the study will receive via a urinary catheter in the
bladder, BCG plus N-803 or N-803 only weekly for 6 consecutive weeks (initial induction
treatment period). After the first disease assessment, eligible patients will receive either
a 3-week maintenance course or a 6-week re-induction course (second treatment period) at
Month 3. Eligible patients will continue to receive maintenance treatment in the third
treatment period at Months 6, 9, 12, and 18. Eligible patients have the option to receive
maintenance treatment in the fourth treatment period at Months 24, 30, and 36. The study
duration is 60 months.
ALT-803 and BCG,
N-803 and BCG
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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